The Enriched Environment as an Integrated Tool in the Ward Setting (ENVIRONMENT)

The Enriched Environment as an Integrated Tool in the Ward Setting for Improving Functional Outcome in People With Acute Stroke: a Study Within the Neurological Clinic Unit

The goal of this longitudinal interventional study is to integrate the enriched environment (EE) in the context of the Neurology Clinic ward of the General Hospital - University of Padua, by verifying its effectiveness and impact on psychological well-being, functional recovery, activity level, and quality of life in people with stroke.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Acute
• Intervention / Treatment: Other: Enriched environment

Detailed Description

The EE will be integrated within the shared areas of the Neurology ward and in inpatient rooms, providing materials and aids to encourage physical, cognitive and social activity. The study will recruit for 9 months plus 6 months of follow-up. It will recruited a total of 50 people with stroke (25 for experimental and control group). After providing informed consent, participants will be evaluated on admission, at discharge, at 4 weeks (follow-up phone interview) and at 6 months (telephone interview). Participants will be psuedo randomized, as the ward will be environmentally enriched during consecutive alternating time frames. The instrument used to measure the multidimensional recovery will be the Stroke Impact Scale. Specific secondary outcomes will assessed the recovery in motor, cognitive and communication function, the impact on physical activity, mood, the type of activity of participants exposed to EE and the impact on the ward organization.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesca Venturini; Phone Number: 049 8212341; Email: ce.sperimentazione@aopd.veneto.it

Study Locations

• Italy
  • Padova, Italy, 35128
    • Recruiting
    • Teaching Hospital, University of Padova
    • Contact: Alessandra Del Felice, MD, PhD; Phone Number: 0039(0)498213600; Email: alessandra.delfelice@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
• Participant consent to participate in the study;
• Mecial stabilisation.

Exclusion Criteria:

• Uncooperative participant, as assessed by theMontreal Cognitive Assessment scale < 15
• medically not stabtability and/or reduced level of consciousness and/or psychomotor agitation;
• Lack of trunk control (score <12 in item 3 of the Trunk Control Test: balance in sitting position) such that it is impossible to maintain a sitting position or a safe posture in a wheelchair;
• Speech evaluation confirming comprehension aphasia hampering understanding of informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enriched environment group; 25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria.	Other: Enriched environment; In the experimental group (enriched environment), assistants will supervise participants sponatneoulsy engaging in activities, including listening to music, drawing, playing cards or board games, exercising the affected upper limb with constructions or puzzles, etc., in the living room and personal rooms. Posters and clocks will also aid in orientation and improve the physical environment.
No Intervention: No intervention; 25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale	The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. SIS is a 59-item measure. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores range from 0-100.	T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ad hoc behavioral mapping checklist	Tool created to quantify and study the type of activity (physical, cognitive, social) carried out by participants.	T0: baseline (enrollment), T1: immediately after intervention (discharge)
Ad hoc questionnaire for health care workers	Assessing impact on ward organisation.	T1: post intervention
Functional Independence Measure (FIM) scale	Functional Independence Measure (FIM) scale is used to assess and grade the functional status of a person based on the level of assistance he or she requires. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126.	T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
Functional Assessment Test for Upper Limb	The Functional Assessment Test for Upper Limb (FAST-UL) is a clinical scale based on observational movement analysis of UL impairment in stroke survivors, composed of 5 items measured through a 4-level ordinal scale.The items identified by the panel of experts are Hand to Mouth (HtM), RtT, PS, GaR, and PaR.	T0: baseline (enrollment), T1: immediately after intervention (discharge)
Functional Ambulatory Category (FAC)	The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Scoring range from 0: nonfunctional ambulator to 5: Ambulator, independent.	T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
Dynamic Gait Index (DGI) if FAC > 3	The Dynamic Gait Index (DGI) is a clinical tool used to assess gait, balance and fall risk. It evaluates not only the usual steady-state walking, but also walking during more challenging tasks. Scores are based on a 4-point scale. Highest possible score is 24 points.	T0: baseline (enrollment), T1: immediately after intervention (discharge)
Oxford Cognitive Screening (OCS)	The Oxford Cognitive Screen (OCS) is a first-line, stroke-specific and domain-specific cognitive screening tool which can be delivered at the bedside in acute stroke.	T0: baseline (enrollment), T1: immediately after intervention (discharge)
Typical values of Physical Activity Level (PAL)	The physical activity level (PAL) is a way to express a person's daily physical activity as a number, and is used to estimate a person's total energy expenditure. Ranges: Extremely inactive PAL <1.40 - Extremely active PAL >2.40.	T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
Hospital Anxiety and Depression Scale (HADS)	Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression. The HADS is a fourteen item scale. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
Motor Activity Log	Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Items scored on a 6-point ordinal scale.	T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Alessandra Del Felice, MD, PhD, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: enriched environment; in-patients setting
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: PROTOCOL_ENVIRONMENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data sheet
• IPD Sharing Time Frame: Upon study completion
• IPD Sharing Access Criteria: Upon direct request of researchers providing any official reaserch identification (ORCID, Reaserch ID, etc)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No